Background: Anastomotic leak rates after colorectal surgery remain high. In most left-sided colon and rectal resection surgeries, a circular stapler is utilized to create the primary bowel anastomosis. However, it remains unclear whether a relationship between circular stapler technology and anastomotic leak in left-sided colorectal surgery exists. Methods: A post-hoc analysis was conducted using a prospectively collected data set of patients from the 2017 European Society of Coloproctology snapshot audit who underwent elective left-sided resection (left hemicolectomy, sigmoid colectomy, or rectal resection) with a manual circular stapled anastomosis. Rates of anastomotic leak and unplanned intensive care unit stay in association with manual circular stapling were assessed. Patient-, disease-, geographical-, and surgeon-related factors as well as stapler brand were explored using multivariable regression models to identify predictors of adverse outcomes. Results: Across 3305 procedures, 8.0% of patients had an anastomotic leak and 2.1% had an unplanned intensive care unit stay. Independent predictors of anastomotic leak were male sex, minimal-access surgery converted to open surgery, and anastomosis height C11 (lower third rectum) (all P < 0.050). Independent predictors of unplanned intensive care unit stay were minimal-access surgery converted to open surgery and American Society of Anesthesiologists grade IV (all P < 0.050). Stapler device brand was not a predictor of anastomotic leak or unplanned intensive care unit stay in multivariable regression analysis. There were no differences in rates of anastomotic leak and unplanned intensive care unit stay according to stapler head diameter, geographical region, or surgeon experience. Conclusion: In patients undergoing left-sided bowel anastomosis, choice of manual circular stapler, in terms of manufacturer or head diameter, is not associated with rates of anastomotic leak and unplanned intensive care unit stay.

To evaluate the incidence of in-hospital bleeding events, and their impact on length of stay (LOS) and critical care utilization, among patients undergoing cancer-directed surgeries in English inpatient hospitals. We conducted a retrospective, observational cohort study using hospital discharge data from English hospitals (Hospital Episode Statistics [HES] database) linked to electronic health records (Clinical Practice Research Datalink [CPRD]). We selected patients aged ≥18 years who underwent one of the following cancer-directed surgeries with a primary diagnosis of cancer between January 2010 and February 2016: hysterectomy, low anterior resection (LAR, rectal), lung (transplant & resection), mastectomy, and prostate (prostatectomy & resection). The primary independent variable was occurrence of in-hospital bleeding events. The primary outcomes were post-procedure LOS and critical care utilization (both in days). We carried out multivariable regression models to compare the study outcomes between patients with vs. without bleeding events, adjusting for patient's baseline demographic and clinical characteristics measured from the CPRD for the year prior to hospital admission. The study included 26,438 cancer-directed surgeries (hysterectomy: 6,092; LAR: 2,957; lung: 1,539; mastectomy: 12,806; prostate: 3,044). Incidence proportions of in-hospital bleeding events varied by surgical site (hysterectomy: 1.9%; LAR: 2.9%; lung: 1.8%; mastectomy: 1.5%; prostate: 1.0%). In the multivariable analyses, patients with bleeding events had longer post-procedure LOS (hysterectomy: 8.0d vs. 4.7d, p<0.0001; LAR: 17.8d vs. 12.1d, p<0.0001; lung: 12.0d vs. 8.6d, p=0.002; mastectomy: 5.3d vs. 2.2d, p<0.0001; prostate: 8.7d vs. 3.6d, p<0.0001) and spent more days in critical care (hysterectomy: 6.9d vs. 0.4d; p<0.0001; LAR: 4.1d vs. 1.5d; p<0.0001; lung: 5.2d vs. 2.0d; p=0.001; mastectomy: 0.5d vs. 0.1d; p=0.02; prostate: 1.5d vs. 0.1d; p=0.03) as compared with patients without bleeding events. Among patients undergoing cancer-directed surgeries in English inpatient hospitals, in-hospital bleeding events were associated with a large inpatient healthcare utilization burden.

Surgical site infections (SSIs) are a common and costly complication, increasing readmission rates, length of hospitalization, mortality, and resulting in overall costs of $3.3 billion to the US healthcare system. Triclosan-coated sutures (TCS) have been demonstrated to reduce the risk of SSI, and large global health authorities recommend their use. The objective of this study was to conduct a budget impact analysis comparing TCS to traditional non-coated sutures (NCS) using the US hospital perspective. An economic model was developed to evaluate the impact of TCS use in the US. Current treatment practices assumed use of NCS, while future practice assumed 50% NCS and 50% TCS use. Each procedure was assumed to require 3 suture units. Surgery types were broken down into clean, clean-contaminated, and contaminated-dirty wounds per CDC definition. NCS and TCS SSI rates by wound type were calculated using data from a systematic review and meta-analysis by Leaper and colleagues. The average of cost per NCS strand and SSI episode were taken from the literature and inflated to 2018 USD. were calculated as costs per patient and population, assuming a hypothetical cohort of 2,000. Sensitivity analyses using conservative estimates for the reductions in the risk of SSIs with TCS were also conducted. The analysis predicted introduction of TCS in the future practice could result in savings of $554.25 per patient due to avoided SSIs. This translated into a potential savings of $1,108,490 when considering a population of 2,000 procedures. of the sensitivity analyses estimated savings for all scenarios tested. Based on the results of this analysis, the increased upfront additional costs of TCS is minimal in comparison to the estimated cost savings from reduced risk of infections versus NCS. TCS should be considered as part of the comprehensive approach for hospitals to address the risk of SSI.

Surgical Site Infections (SSIs) are serious complications related to surgical procedures with a potential high impact on healthcare expenditure. Triclosan-Coated Sutures (TCS) have been demonstrated to reduce the risk of SSI and many guidelines, both internationally and locally, recommend their use. This study aims at assessing the economic impact of the introduction into clinical practice of TCS in replacement of Non-Coated Sutures (NCS) from an Italian Hospital Perspective, based on more recent published evidence. An economic model was developed to estimate the impact on budget deriving from the introduction of absorbable TCS into clinical practice with a time horizon of 1 year. The overall SSI risk was obtained from the Italian National Surveillance and the TCS SSI risk reduction was taken from a systematic review and meta-analysis published by Leaper et al. in 2017. The incremental cost of TCS with respect to NCS strand and the average SSI episode cost were taken from the Italian average selling price and an Italian literature review, respectively. Based on the most recent National SSI Surveillance report, the overall SSI rate in Italy is 1.3%. The SSI reduction related to the use of Triclosan-Coated Sutures as from Leaper et al. meta-analysis is 39%, while the reported SSI inpatient average cost per episode is € 9,560. The model assumed 1,000 surgical procedures, 5 absorbable sutures per procedure and an incremental cost of TCS respect to NCS equal to € 0.79. On the basis of these assumptions, an overall expenditure of € 129,710 for TCS and of € 83,228 for NCS was estimated, resulting in a net saving of € 46,482 for the hospital. The introduction of TCS into Italian hospital clinical practice is estimated to be cost-saving by reducing SSI risk, resulting in a solution that optimizes healthcare expenditure.

Wound closure is a key component of knee arthroplasty. Innovative technologies, such as the DERMABOND® PRINEO® Skin Closure System (skin closure system) and STRATAFIX™ Knotless Tissue Control Devices (barbed suture) provide improved wound closure strength, antimicrobial benefits, and improved patient outcomes (i.e. ability to shower and no dressings required). The objective of this study is to estimate the hospitals's economic impact using a skin closure system and barbed sutures compared to conventional wound closure methods during knee arthroplasty; in France, Germany, Italy, and the Netherlands. An economic model was developed in which a current treatment pathway (using traditional absorbable sutures for deeper tissue closure and staples/sutures for the final skin layer) was compared to a future practice (introducing the use of barbed sutures and the skin closure system). Healthcare resources associated with knee arthroplasty included final skin layer materials, deeper tissue layer sutures, dressings (standard or premium), operating room time, length of hospital stay, surgical site infections, outpatient visits, and hospital readmissions up to 90 days. Resource use for each parameter was based on country specific literature, expert clinical opinion and database findings. Costs were based on appropriate country sources for each of the four countries analysed. Compared to a current practice using traditional absorbable sutures and staples/sutures, use of the skin closure system and barbed suture in the future practice was predicted to result in cost savings to hospitals. By country, cost savings per patient ranged from €326 to €335 (France), €357 to €366 (Germany), €419 to €428 (Italy), and €590 to €599 (the Netherlands), depending on the dressing type used. Results of the economic analysis suggest that the introduction of the skin closure system and barbed suture for wound closure in knee arthroplasty can save costs to European hospitals due to reduced intra- and post-operative resource use.

Identification of surgical complications in real-world settings is important to understanding associated burden of illness and unmet needs. Using the linked Clinical Practice Research Datalink (CPRD)/Hospital Episode Statistics (HES) databases, this study evaluated the impact of varying definitions of surgical bleeding complications on incidence and association with hospital length of stay (LOS) in U.K. patients who underwent selected in-hospital surgeries. Patients age≥18y who underwent selected in-hospital surgeries (cholecystectomy, cardiac surgery, hernia repair, hysterectomy, knee/hip arthroplasty, low anterior resection, lung surgery, mastectomy, prostate surgery) between 2010Q1-2016Q1 were identified from the linked CPRD/HES databases. Surgical bleeding complications from date of surgery through discharge were identified using three alternative definitions: (1) primary definition: haemorrhage/haematoma complicating a procedure and/or bleeding reintervention/reoperation; (2) strict definition: reoperation for surgical arrest of bleeding; (3) broad definition: primary definition+broader set of diagnoses and reintervention/reoperation procedures. Multivariable generalized linear models evaluated the impact of surgical bleeding complications on hospital LOS from date of surgery through discharge. Study included 134,316 eligible surgical patients (51% age≥65yr; 55% female; 91% elective admissions). Incidence proportions of surgical bleeding complications from date of surgery through discharge were: 1.4% primary definition; 0.1% strict definition; 1.9% broad definition; incidence proportions varied substantially among the surgeries, ranging from 6.7% in cardiac surgery to 0.7% in knee/hip arthroplasty (primary definition). In multivariable models adjusting for patient and procedure characteristics, surgical bleeding complications were associated with significantly increased LOS: 10.2d vs. 4.8d primary definition (p<0.0001); 9.8d vs. 4.7d broad definition (p<0.0001); and 15.7d vs. 4.9d strict definition (p<0.0001). In the linked CPRD/HES databases, the chosen method of defining surgical bleeding complications can lead to substantial variation in estimated incidence proportions; however, all significantly increase LOS. Improved bleeding management may reduce the clinical and economic burden associated with perioperative bleeding complications.

Flowable hemostatic agents are absorbable gelatin-thrombin matrices indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. Prior literature demonstrated similar efficacy with regard to control of bleeding between the most widely-used agents, SURGIFLO® Hemostatic Matrix and FLOSEAL Hemostatic Matrix, via direct and indirect comparisons. The objective of this retrospective patient chart review was to assess the economic burden in Germany by collecting hospital resource utilisation data among patients who underwent spine surgery (osteosynthesis with / without spondylodesis) using SURGIFLO® with Thrombin (SFwT) or FLOSEAL (FS). Eligible physicians were selected from healthcare panels. They included patients with osteosynthesis with implementation of a screw-rod system based on medical files and surgical reports. Analyses were performed on Full Analysis Set (FAS) and Non-Outlier Set (NOS). Outliers were defined as patients >3 standard deviations from FAS means. Statistical significances were calculated using Student’s T-test and chi-quadrat-test. To assess economic burden, a linear model including treatment group, age, gender, and number of vertebrae fused was applied. 89 physicians from 42 hospitals selected 421 patients (FAS). Of these, 390 patients comprised the NOS (median age: 66y, 54% male, 30.5% SFwT-treated patients, 69.5% FS-treated patients). Economic burden was significantly higher in FS-treated patients by 128.36€ (p<0.0001). No statistically significant differences between SFwT- and FS-treated patients were observed for surgery duration or blood loss. FAS and NOS did not differ regarding significances. This study provides real-world utilisation data on the use of flowable hemostatic agents and associated economic burden in Germany. Cost analyses favor utilisation of SURGIFLOTM with Thrombin in spine surgeries with implementation of a screw-rod system. Analyses of additional hospital resource utilisation data are ongoing and will be published at a future date.

Bleeding is a serious complication related to Coronary Artery Bypass Grafting (CABG) surgery with a potential high impact on clinical outcomes and health care services expenditure. The aim of this study is to evaluate the impact on economic resource consumption associated with the use of fibrin sealants in a comparative analysis between Evicel and Tisseel. Analysis was developed to estimate the impact on costs associated with use of Evicel and Tisseel from the Italian National Healthcare System perspective with a 30-day time horizon, including the following item costs: fibrin sealant use, blood transfusion, readmissions. A literature research was performed to assess efficacy data in terms of blood transfusion rate and 30-day readmission rate associated with both fibrin sealants. The economic data on blood transfusion and fibrin sealant use were estimated on basis of the corresponding national reimbursement fees, while the costs associated with readmission were estimated according to DRG tariffs. Univariate sensitivity analysis was conducted to determine whether results were insensitive to variations in uncertain parameters. The literature research showed a lower blood transfusion rate on the index CABG surgery date (19% versus 34%) and after index date (9% versus 15%), as well as, a lower readmission rate (16% vs. 31.9%) in favor of use of Evicel. The economic analysis showed a lower transfusion cost for Evicel than Tisseel 22.64% (€ 65.60 versus € 84.80) and a lower readmission costs of 43.75% (€ 1,148.87 versus € 2,042.43), showing a total cost savings of € 1,045.20 per patient, including fibrin sealant cost. The sensitivity analysis shows that resulting cost-saving was most sensitive to 30-day readmission associated with the fibrin sealants. Detailed comparative analysis of the data has specifically shown that during CABG surgery, Evicel is associated with lower bleeding events and lower health-resource utilization/cost than Tisseel.

Surgical bleeding can become problematic depending on factors such as bleeding intensity, anatomic location, and coagulation status. Problematic surgical bleeding is frequently associated with important clinical and cost burden. The objective of this study was to conduct a hospital budget impact analysis of a novel fibrin sealant matrix (EVARREST®) versus standard of care (SoC) in severe soft-tissue surgical bleeding in France. A hospital budget impact model quantified 30-day cost impact of EVARREST® in France. The severe soft-tissue bleeding trial (n=91) collected resources including quantity of initial treatment, re-treatment, surgery time, transfusions, and hospitalization (including ICU and ward stay). SoC was composed of oxidized regenerated cellulose (88%) and conventional methods such as manual compression. The surgical analysis included resources clinically related to the significant hemostasis benefit of EVARREST® vs. SoC (i.e., initial and re-treatment, operating time, transfusion). A hospital analysis included all resources collected. Published France unit costs were applied to resource use. Value-added tax was added to product costs. A subgroup analysis (n=19) was conducted in potentially coagulopathic patients of the trial, defined as those meeting criteria for abnormal coagulation parameters. In severe soft-tissue bleeding, the analysis predicted that the cost of EVARREST® was substantially offset by averted resources, leading to an overall cost impact of only €771 (hospital analysis) to €1,496 (surgical analysis) per patient. In the subgroup analysis of potentially coagulopathic patients, EVARREST® no longer had a cost impact, rather was predicted to be cost saving in both the surgical (€730) and hospital (€2,368) analyses versus SoC. This analysis of a severe soft-tissue bleeding trial predicts EVARREST® may result in important cost efficiencies for hospitals compared with SoC. The findings suggest results may depend on bleeding type, with increased benefit predicted in more problematic (i.e., potentially coagulopathic) bleeding situations. Further study is needed to confirm findings.

Background:In addition to rapid and sustained efficacy, ease of use is also an important characteristic of topical hemostats.Objectives:To evaluate clinician-reported ease of use for the Evarrest fibrin sealant patch across various surgical bleeding situations.Methods:An ease of use questionnaire (EUQ) was validated and administered in four randomized studies comparing the fibrin sealant patch to standard of care (SoC) in soft tissue and hepatic surgical bleeding. Three of these randomized studies have been previously published and all have been registered (NCT00658723; NCT00977925; NCT01166243; NCT01993888). The EUQ is a 19 item instrument evaluating clinician’s preferences on five subscales: product ease of use, satisfaction with product properties and efficiency, confidence in product efficacy, global confidence, and global satisfaction. A pair-wise meta-analysis using a random effects model was conducted on EUQ scores for trials that reported data for both treatment arms. Individual scores are presented for each trial.Results:The fibrin sealant patch demonstrated numerically greater scores than SoC in all EUQ subscales. The meta-analysis demonstrated that fibrin sealant patch scores improved for all subscales compared with SoC: satisfaction with product properties (mean difference [MD] = 0.38, 95% CI: 0.04 to 0.73; P = 0.03), confidence in efficacy (MD = 1.10, 95% CI: 0.47 to 1.74; P = 0.0007), global confidence (MD = 0.57, 95% CI: 0.05 to 1.10, P = 0.03), global satisfaction (MD = 0.79, 95% CI: 0.32 to 1.26, P = 0.001), and ease of use (MD = 0.33, 95% CI: -0.29 to 0.94; P = 0.23). Fibrin sealant patch single arm trial results aligned with these findings.Conclusions:Physicians consistently reported high EUQ scores for the fibrin sealant patch across surgical bleeding populations. An important limitation of this study was that the composition of SoC varied across studies and EUQ data were only available for the SoC in two of four trials. Future studies should evaluate ease of use for other hemostats and across other surgical subspecialties, as data are currently limited.

Bleeding in liver surgery can be difficult to control due to extreme vascularity and tissue fragility, including compromised liver (e.g., cancer). Blood loss may be minimized with hemostats that have rapid effect and may impact cost of care. This study estimated budget impact of using EVARREST vs. SoC in hepatic surgery based on two randomized trials. An economic analysis was developed to quantify 30-day cost impact of EVARREST from a U.S. hospital perspective. Key resources, from two randomized trials (n=180), included initial treatment, retreatment, operating time, transfusions, ventilator, and hospitalization. Transplant patients (n=6) where normal liver tissue was resected were excluded from analyses. SOC was composed mainly of manual compression alone or with hemostats. The surgical analysis included resources clinically related to significant hemostasis benefits of EVARREST (i.e. retreatment, operating time, transfusion). A hospital analysis included all resources collected. Economic analyses were completed for the following subgroups: abnormal liver, metastatic cancer, anatomic/non-anatomic liver (classifications using IHPBA definitions), cirrhotic/steatotic liver, and if patients were obese or coagulopathic. Published U.S. costs were applied to resource use. Analysis results were weighted based on trial size. The surgical analysis predicted that the EVARREST cost was offset vs. SoC with a trial-weighted cost impact of $719 per patient. The hospital analysis predicted further resource reduction with EVARREST with trial-weighted cost-savings of $868 per patient. Subgroup analyses demonstrated a range of results from cost impact to cost savings with EVARREST vs. SOC (i.e., $1,976 to -$5,430 per patient, hospital analysis). EVARREST use in coagulopathic patients was found to have the largest degree of cost savings with $1,859 and $5,176 per patient anticipated, surgical and hospital results respectively. In addition to meeting an important unmet need in controlling problematic bleeding in liver tissue, this analysis suggests that EVARREST can be a cost saving strategy.

Surgical bleeding remains prevalent and associated with substantial burden. Such bleeding can be more difficult to manage in certain surgeries (e.g., liver). Hemostats with a fibrinogen, thrombin and patch component may be especially beneficial for problematic bleeding types; however, direct comparative data are limited. This study indirectly compared the hemostats EVARREST and TachoSil. A structured literature search identified studies of fibrin sealants combined with use of a pad, patch, fleece or sponge, for surgical bleeding. The search was restricted to RCTs, 2000 onward, studies including standard of care (SoC) and time to hemostasis (TTH). EVARREST (4 trials) and TachoSil (6 trials) were identified as the comparators. Pair-wise meta-analyses were completed using a random-effects model for hemostat vs. SoC. An adjusted indirect comparison was conducted using Bucher methodology and ITC software (Wells, 2009) for calculating the mean difference (MD) in TTH between EVARREST and TachoSil with 95% confidence intervals (CI). Mean TTH was analysed as it is a well-accepted, recommended measure. Typically, TTH measurements began at either 3 or 4 minutes. SoC was used as the ‘anchor’ to perform the indirect comparison and consisted of either conventional methods or topical hemostats. Indirect comparisons were completed for all surgery types and a liver surgery subgroup. A total of 894 patients were assessed. Across surgery types, the adjusted indirect comparison demonstrated EVARREST reduced mean TTH by 1.15 minutes compared to TachoSil (MD: -1.15; 95%CI: -3.29, 0.99), however, this difference was not statistically significant. In the subgroup of liver surgical bleeding, EVARREST significantly reduced mean TTH by 2.73 minutes (MD: -2.73; 95%CI: -4.48, -0.981). This analysis suggests EVARREST may provide better hemostasis than TachoSil, particularly in liver surgical bleeding. Caution must be taken in interpreting results given some patient differences. A head-to-head trial comparison may be necessary to confirm differences between products.

Intraoperative watertight dural closure is critical as CSF leakage can lead to an increased risk of costly clinical consequences (e.g., wound infection, meningitis). Although there are several fibrin sealants available, not all are indicated for sealing dura mater. An economic analysis compared a fibrin sealant (EVICEL® Solutions for Sealant) with standard of care (SoC) for sutured dural closure in cranial surgery in the United Kingdom (UK). The economic analysis quantified the 30-day cost impact of EVICEL® from a U.K. hospital perspective based on a surgical approach using clinical trial data. SoC was composed of sutures in addition to rescue therapy for the majority of the population. Trial-reported resources used included the quantity of initial treatment, adjunctive and rescue therapy product utilization, operating room (OR) time, hospitalization duration, and risk of dural-related adverse events. Only SoC treatment successes were allowed to receive additional adjunctive therapies to ensure durability of closure; however, treatment failures in both Evicel® and SoC could receive rescue therapies. Adjunctive therapies consisted of sutures, collagen, and haemostats (not fibrin sealants); where as rescue therapies consisted of various glues, haemostats and autologous dural patches. Published data on U.K. costs were applied to resource use and several one-way sensitivity analyses were conducted. The analysis estimated that resource savings with EVICEL® completely offset its acquisition cost and resulted in cost savings of £207 per patient (sensitivity range: -£727.02 to £313.40) compared with SoC. Results remained robust to the majority of sensitivity analyses; however were most sensitive to assumptions regarding OR time and hospitalization duration. The use of EVICEL® for suture line dural closure may result in important cost savings for hospitals, partly driven by the reduced need for other adjunctive and rescue therapies. Further studies in larger populations may help to substantiate findings.

A recent Premier study reported that despite hemostat use, uncontrolled bleeding is prevalent across surgery types (32%-68%). Drawbacks of current hemostats include limitations with efficacy on first attempt and sub-optimal ease-of-use; thus, better hemostats are needed. A study was conducted to estimate the cost impact of a novel fibrin sealant patch (EVARREST™) versus standard of care (SoC) in soft tissue and hepatic surgical bleeding. An economic model quantified 30-day cost impact of EVARREST from a U.S. hospital perspective. Key resources, from four trials, included quantity of initial treatment, re-treatment, operating time, hospitalization, transfusion risk, amount transfused, and ventilator utilization. SoC was composed of Surgicel (88% to 100% in soft tissue, 34% to 65% in hepatic tissue) and conventional methods (e.g., manual compression, thrombin). Transplant patients were excluded from analyses. The surgical analysis included resources clinically related to the significant hemostasis benefit of EVARREST vs. control (i.e., initial and re-treatment, operating time, transfusion). A hospital analysis included all resources collected. Published data on U.S. costs were applied to resource use. Sensitivity analyses were conducted on several variables including number of EVARREST products used. The surgical base-case analysis predicted that EVARREST was cost saving vs. SoC by $59 per patient (sensitivity range: -$300 to $900). The hospital analysis predicts further resource reduction with EVARREST with cost-savings of $2,789 per patient (sensitivity range: -$1,830 to -$3,338). Results were most sensitive to the number of pads used. Composite results were primarily driven by the large benefit achieved with EVARREST in severe soft-tissue bleeding. In problematic soft tissue and hepatic bleeding, EVARREST may result in important cost savings for hospitals, in addition to meeting an important unmet need. This analysis suggests EVARREST’s impact on hospital cost may depend on surgical bleeding type and number of pads used. Further study in additional populations may confirm findings.

Although several hemostats are available, drawbacks include limitations with efficacy and ease-of-use. Despite their use, uncontrolled bleeding still remains common and is associated with important clinical and economic burden. A study was conducted to estimate the economic impact of a novel fibrin sealant matrix (EVARREST®) versus standard of care (SoC) in problematic severe soft tissue surgical bleeding in Italy. An economic model quantified 30-day cost impact of EVARREST® from an Italian hospital perspective. Severe soft tissue bleeding trial resources included quantity of initial treatment, re-treatment, surgery time, transfusion risk, amount transfused, and hospitalization (including ICU and ward stay). SoC was composed of Surgicel® (88%) and conventional methods (e.g., manual compression). The surgical analysis included resources clinically related to the significant hemostasis benefit of EVARREST®vs. SoC (i.e., initial and re-treatment, operating time, transfusion). A hospital analysis included all resources collected. Published data on Italian costs were applied to resource use. A subgroup analysis was conducted for patients meeting coagulopathic criteria based on abnormal values for at least one of the trial coagulation parameters collected. The surgical base-case analysis predicted that EVARREST® cost was offset by averted resource use with per patient cost impact of €1,016 vs. SoC. The hospital analysis predicts further resource reduction with EVARREST® leading to cost-savings of €708 per patient. In coagulopathic patients, the results dramatically improved, with the surgical and hospital analysis both showing cost-savings of €2,366 and €6,128, with EVARREST®vs. SoC respectively. In problematic bleeding situations, EVARREST® may result in important cost savings for hospitals, in addition to meeting an important unmet need. This analysis suggests results may depend on surgical bleeding type, with increased benefit seen in challenging (i.e., coagulopathic) bleeding patients. Further study is needed to confirm findings.

In the UK, anastomotic leak rate after colorectal surgeries has been reported up to 19%. Yet, clinical and economic consequences of anastomotic leak have not been clearly articulated. Our study aims to estimate the clinical/economic burden of anastomotic leak following colorectal surgeries in the UK. The Hospital Episode Statistics database was used to identify English National Health Service Trust adult patients undergoing colorectal surgeries between January 2007 and December 2011. Anastomotic leak was identified by re-intervention/diagnosis codes within a 30-day window following colorectal surgery, including re-operation, re-anastomosis, stent, colostomy, image guided drainage, washout procedure, abscess/drainage and diagnosis of generalized (acute) peritonitis. Hospital costs were calculated using Healthcare Resource Group and Department of Health reference index costs. Differences in outcomes between groups were compared using a propensity score matching approach, adjusting for age, gender, admission method, surgery type, comorbidity and medical stabilization. A total of 131,689 patients received colorectal surgeries (mean age: 65.2±15.4, male: 50.4%). The rate of anastomotic leak following colorectal surgery was 6.4% (8,404 out of 131,689). After propensity score matching by key covariates, Patients with leak (vs. without leak) had higher in-hospital mortality (15.9% (95% CI: 15.2%, 16.7%) vs. 6.2% (95% CI: 5.7%, 6.7%), p<0.001), 30-day readmission rate (19.7% vs. 11.6%, p<0.001), and post-operative infection rate (19.3% vs. 4.5%, p<0.001). The hospitalizations for patients with leak (vs. without leak) were more costly (£9,071±£4,588 vs. £6,420±£2,895, p<0.001) and longer (20±23 vs. 11±13 days, p<0.001). Anastomotic leak resulted in an additional cost of £2651 and an extra LOS of 9 days per patient. Our findings underscore the clinical/economic burden of anastomotic leak after colorectal surgeries in the UK. The presence of anastomotic leak was associated with greater mortality, LOS, and costs, highlighting the importance of providing prompt medical attention to minimize the impact of anastomotic leak.

Hemostasis after liver resection may be difficult to achieve and there is thus an increased focus on reducing blood loss and resource use with hemostatic products. This study estimated the cost impact of a novel fibrin sealant patch (i.e., EVARREST) vs. standard of care (SoC) for bleeding control in hepatic resection. An economic analysis quantified 30-day cost impact of EVARREST vs. SoC from a German hospital perspective. This analysis used data from a randomized trial, which included aggregated resource use reported within 30 days. Resources included initial treatment and re-treatment, operating time, hospitalization, transfusions, and ventilator. SoC was composed of manual compression with a small percentage using hemostats. The primary analysis included resources clinically related to the significant hemostasis benefit of EVARREST vs. SoC (i.e., initial treatment and re-treatment with hemostasis methods, operating time, transfusions, and blood units). A secondary analysis included all resources evaluated in the primary analysis with the addition of hospital stay, proportion of patients using ventilator, and mean ventilator hours. A projected global price for EVARREST was used based on average USD to Euro exchange rate over the last 10 years. Published data on German costs were applied to resource use. Sensitivity analyses were conducted on several variables including EVARREST costs (€472 to €735) for available sizes. The primary analysis predicted that EVARREST acquisition cost is offset with cost impact reduced to €82 per patient vs. SoC (sensitivity range: -€86 to €225). Secondary analyses predicted further resource reduction with EVARREST leading to cost-savings (i.e., -€458 per patient). Operating time and hospital stay were important analysis drivers. This analysis suggests that EVARREST may result in cost savings, in addition to meeting an important unmet need for controlling bleeding in hepatic surgery. Further study in more patients may be required to confirm findings.

Although there are several hemostats available, drawbacks include limitations with efficacy on first attempt and sub-optimal ease-of-use. Literature suggests that more efficacious hemostats may avert hospital resources and offset upfront acquisition costs. A study was conducted to estimate the cost impact of a novel fibrin sealant patch (i.e., EVARREST™) versus standard of care (SoC) in mild-moderate and problematic soft tissue surgical bleeding. An economic model was developed to quantify 30-day cost impact of EVARREST from a U.S. hospital perspective. Key resources, collected from two trials, included quantity of initial treatment and re-treatment, operating time, hospitalization, transfusion risk, amount transfused, and ventilator utilization. SoC was composed of Surgicel (mild-moderate bleeding) or Surgicel (88%) and conventional methods (12%) (problematic bleeding). The primary analysis included resources clinically related to the significant hemostasis benefit of EVARREST vs. control (i.e., initial and re-treatment, operating time and transfusion). A secondary analysis included all resources collected. Published data on U.S. costs were applied to resource use. In problematic bleeding, the primary analysis predicted that EVARREST is cost-savings for the hospital vs. SoC (-$462 USD per patient) with robust one-way sensitivity results (range: -$199 to -$6,212 USD). In mild-moderate bleeding, EVARREST acquisition cost is partially offset with a cost impact of $507 USD per patient (sensitivity range: $175 to $851 USD). Secondary analyses predicted further resource reduction with EVARREST leading to cost-savings (-$5,096 USD per patient) or reduction in cost impact ($233 USD per patient) for problematic and mild-moderate bleeding respectively. This analysis suggests that the hospital cost impact of EVARREST depends on type of bleed. In problematic soft tissue bleeding, EVARREST may result in important cost savings for hospitals, in addition to meeting an important unmet need. Further study in additional populations may be required to confirm findings.